Modified Sternal Precautions Versus Conventional Sternal Precautions in Physical Function After Sternotomy
31 mei 2022 bijgewerkt door: Riphah International University
Effectiveness of Modified Sternal Precautions Versus Conventional Sternal Precautions in Improving Physical Function After Sternotomy
This research study Effectiveness of modified sternal precautions versus conventional sternal precautions in improving physical function after sternotomy .After recruitment of the subjects, the intervention group will receive modified sternal precaution while the control group will receive conventional sternal precautions and they will be assess for their physical activity, kinesiophobia, quality of life and post sternotomy pain.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This study will address the scarcity of research and the variations in recommendations regarding sternal precautions and restrictions of upper limb movement in cardiac patients and will help to evaluate the effect of modified sternal precautions on patients' pain and functional activity.
As physical therapists are the ones who have maximum exposure to practice and teaching of sternal precautions, therefore this study will help to formulate the guidelines regarding the use of upper limb during cardiac rehabilitation exercises and making standards for sternal precautions and its management following cardiac surgery.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
KPK
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Peshawar, KPK, Pakistan, 25000
- Rehman Medical Institute
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
40 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
Inclusion Criteria:
- Open heart surgery patients (CABG and Valve surgeries)
Exclusion Criteria:
- Unstable vitals
- Patient needing maximum assistance
- Decline consent
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Modified sternal precautions
Interventional group (Modified sternal precautions)
|
Use pain and discomfort to guide the safe use of the arms Avoid pushing or pulling with one arm Use both arms close to the body during lifting Use of arms is possible, but keep them close to the body Avoid stretching one or both arms backwards at the same time Use a cushion or perform sternal preservation technique (crossing the arms in a 'self-hugging 'posture) when coughing. When transferring, roll onto the side, ease the legs over the edge of the bed and carefully use the arms to sit up from a lying position |
|
Actieve vergelijker: Conventional sternal precautions
Control group (Conventional sternal precautions)
|
Avoid pushing or pulling through the arms Avoid one-arm (unilateral) activity Limit the elevation of the arms to 90 degrees Avoid lifting objects heavier than 2 kg Use a cushion or perform sternal preservation technique (crossing the arms in a 'self-hugging' posture) when coughing Limit the use of the arms when transferring from sitting to standing and getting out of bed Avoid placing the arms behind the back
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Short physical performance battery
Tijdsspanne: 4 Week
|
SPBB is a commonly used tool in clinical setting for measuring the physical performance of patients.
It is known for its feasibility and shorter time to conduct.
It has been used in different studies for reporting outcome measure post cardiac surgery.
This outcome measure is also selected due to its high validity and reliability.
The reliability of the test is 0.87.
It is divided into three subtests: balance, a short walk at normal pace and lastly standing up from a chair five times repeatedly.
These subsets exemplify core tasks being important for independent living.
|
4 Week
|
|
Functional difficulties questionnaire
Tijdsspanne: 4 week
|
Functional difficulties questionnaire is a functional outcome measures that specially focuses on the thoracic region and upper limb movements in people following cardiac surgery.
The validity of the questionnaire is 0.971 while its reliability is 0.918.
The questionnaire is divided into 13 questions which consists of functional tasks, causing difficulty following cardiac surgery.
Participants are required to mark on an unmarked 10cm VAS the level of difficulty they experienced when completing each of the included tasks, based on the previous time they experience.
|
4 week
|
|
Tampa scale of Kinesiophobia (TSK-II)
Tijdsspanne: 4 week
|
It is a broadly used tool to measure pain related fear beliefs regarding movement and re-injury.
The validly of the questionnaire range between 0.74 to 0.87 and its reliability is 0.747.
It is a self-reported questionnaire.
It includes 11 questions scale on likert scale ranging from 1 to 4 where 1 means strongly disagree while 4 means strongly agree.
The total score ranges between 11 to 44.
Higher score indicate high level of kinesiopobhia.
A reduction of points equal or more than 3 points accounting for about 10% is considered as relevant change.
|
4 week
|
|
Mcgill pain questionnaire - short form version 2 (SF-MPQ-2)
Tijdsspanne: 4 Week
|
It is one of the most widely used questionnaire for the measurement of pain.
Its benefit is that it provides valuable information on the sensory, affective and evaluative dimensions of pain experience by an individual.
It has a capability of discriminating among different types of pain problems.
It has become one of the most commonly used tests for the measurement of pain following cardiac surgery via sternotomy.
The reliability of the questionnaire ranges from 0.75 to 0.83.
|
4 Week
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Health survey (SF-36)
Tijdsspanne: 4 week
|
This questionnaire provides overall measure of quality of recovery of patient according to the patient's perspective.
It is a reliable and valid tool used mainly in clinical practices to measure health related quality of life following cardiac surgery.
The reliability of scale is 0.65 to 0.96.
This tool consists of eight domains comprising of physical functioning, role physical functioning, role emotional functioning, mental health, vitality, social functioning, bodily pain and general health.
Responses are recorded on a five-point Likert scale and then transformed onto a 100-point scale.
Score higher than 50 shows better health state and less pain experienced
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4 week
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.
- Price KJ, Gordon BA, Bird SR, Benson AC. A review of guidelines for cardiac rehabilitation exercise programmes: Is there an international consensus? Eur J Prev Cardiol. 2016 Nov;23(16):1715-1733. doi: 10.1177/2047487316657669. Epub 2016 Jun 27.
- Epstein AJ, Polsky D, Yang F, Yang L, Groeneveld PW. Coronary revascularization trends in the United States, 2001-2008. JAMA. 2011 May 4;305(17):1769-76. doi: 10.1001/jama.2011.551.
- Deb S, Wijeysundera HC, Ko DT, Tsubota H, Hill S, Fremes SE. Coronary artery bypass graft surgery vs percutaneous interventions in coronary revascularization: a systematic review. JAMA. 2013 Nov 20;310(19):2086-95. doi: 10.1001/jama.2013.281718.
- Hodge T. Fast Facts for the Cardiac Surgery Nurse: Caring for Cardiac Surgery Patients in a Nutshell: Springer Publishing Company; 2015.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
19 september 2020
Primaire voltooiing (Werkelijk)
28 maart 2021
Studie voltooiing (Werkelijk)
31 maart 2021
Studieregistratiedata
Eerst ingediend
2 februari 2021
Eerst ingediend dat voldeed aan de QC-criteria
4 februari 2021
Eerst geplaatst (Werkelijk)
5 februari 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
1 juni 2022
Laatste update ingediend die voldeed aan QC-criteria
31 mei 2022
Laatst geverifieerd
1 mei 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- REC00707 Huma Balqias
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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